This Notice modifies the language of RFA-RM-10-020 with regard to the section on Special Program Requirements part 20 (Required
Institutional Letters) and the section on Format of the Application part I (Human
Subjects) to address reporting of serious and unexpected adverse events.

In RFA-RM-10-020,
part 20 (Required Institutional Letters) of the section on Special Program
Requirements currently reads:

20.
Required Institutional Letters

Applicants must provide letters from the appropriate
high-ranking institutional official(s) from the parent institution(s) and its
affiliates that:

commit the institutions to the CTSA's goals, indicating that the
program will be integral to a broad institutional vision for clinical and
translational research

supply evidence of active clinical and translational research
facilities, faculty and research projects; an integrated training environment;
and other resources

indicate institutional support. There is no cost sharing
requirement under this FOA. However, indication of institutional support will
be considered as a strength in the review of these applications. Co-funding or
matching funds from other sources (including industry) are encouraged, as long
as these funds do not limit faculty or trainee choices at any point and there
are methods in place to ensure transparency, prevent misuse of federal funds,
and ensure that NIH policies with respect to sharing of data and resources,
academic freedom, and publication rights are not violated

state how trainees' and investigators' time commitments to
clinical and translational research will be supported, managed and protected

commit the institution(s) to working towards adopting and
implementing best practices identified through CTSA Key Function committees

commit the PI and all the appropriate technology transfer offices
to the data and resource sharing plans specified in the application

specify any collaborative arrangements made with another CTSA
that share workload or goals.

This is hereby replaced with:

20.
Required Institutional Letters

Applicants must provide letters from the appropriate
high-ranking institutional official(s) from the parent institution(s) and its
affiliates that:

commit the institutions to the CTSA's goals, indicating that the program
will be integral to a broad institutional vision for clinical and translational
research

supply evidence of active clinical and translational research
facilities, faculty and research projects; an integrated training environment;
and other resources

indicate institutional support. There is no cost sharing
requirement under this FOA. However, indication of institutional support will
be considered as a strength in the review of these applications. Co-funding or
matching funds from other sources (including industry) are encouraged, as long
as these funds do not limit faculty or trainee choices at any point and there
are methods in place to ensure transparency, prevent misuse of federal funds,
and ensure that NIH policies with respect to sharing of data and resources,
academic freedom, and publication rights are not violated

state how trainees' and investigators' time commitments to
clinical and translational research will be supported, managed and protected

commit the institution(s) to working towards adopting and
implementing best practices identified through CTSA Key Function committees

commit the PI and all the appropriate technology transfer offices
to the data and resource sharing plans specified in the application

specify any collaborative arrangements made with another CTSA
that share workload or goals

commit to notify NCRR of adverse events in all clinical studies
supported by the CTSA that are both serious and unexpected.

In RFA-RM-10-020,
part I (Human Subjects) of the section on Format of the Application currently

does not have content:

I. Human Subjects

This is hereby replaced with:

I. Human Subjects

Where appropriate, discuss plans for ensuring necessary
medical or professional intervention in the event of adverse effects to the
subjects in studies supported by the CTSA. If studies that involve clinical
trials (biomedical and behavioral intervention studies) are to be supported by the
CTSA, include a general description of the plan for data and safety
monitoring of such studies and adverse event reporting to the IRB, NCRR, NIH,
and others, as appropriate, to ensure the safety of subjects.